[Federal Register: September 29, 1998 (Volume 63, Number 188)] [Rules and Regulations] [Page 51820-51821] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr29se98-16] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520 Oral Dosage Form New Animal Drugs; Streptomycin Oral Solution AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Contemporary Products, Inc. The ANADA provides for the use of streptomycin oral solution in drinking water for the treatment of nonspecific infectious enteritis in chickens and for the treatment of bacterial enteritis in swine and calves. EFFECTIVE DATE: September 29, 1998. FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209. SUPPLEMENTARY INFORMATION: Contemporary Products, Inc., 3788 Elm Springs Rd., P.O. Box 6067, Springdale, AR 72766-6067, filed ANADA 200- 197 that provides for the use of streptomycin oral solution in drinking water for the treatment of nonspecific infectious enteritis in chickens and for the treatment of bacterial enteritis in swine and calves. Contemporary Products, Inc.'s ANADA 200-197 is approved as a generic copy of Veterinary Services, Inc.'s NADA 065-252. ANADA 200-197 is approved as of August 3, 1998, and the regulations are amended in 21 CFR 520.2158a to reflect the approval. The basis for approval is discussed in the freedom of information summary. Contemporary Products, Inc., is not currently listed in the animal drug regulations as the sponsor of an approved application. At this time, 21 CFR 510.600(c)(1) and (c)(2) are amended by adding a new listing for the sponsor. In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. [[Page 51821]] 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 520 are amended as follows: PART 510--NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. Section 510.600 is amended in the table in paragraph (c)(1) by alphabetically adding a new entry for ``Contemporary Products, Inc.'' and in the table in paragraph (c)(2) by numerically adding a new entry for ``055462'' to read as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * ------------------------------------------------------------------------ Firm name and address Drug labeler code ------------------------------------------------------------------------ * * * * * * * Contemporary Products, Inc., 3788 Elm Springs Rd., Springdale, AR 72764-6067 055462 * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 055462............ Contemporary Products, Inc., 3788 Elm Springs Rd., Springdale, AR 72764-6067 * * * * * * * ------------------------------------------------------------------------ PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.2158a [Amended] 4. Section 520.2158a Streptomycin sulfate oral solution is amended in paragraph (b) by removing the phrase ``No. 033008'' and adding in its place `` Nos. 033008 and 055462''. Dated: August 27, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 98-25904 Filed 9-28-98; 8:45 am] BILLING CODE 4160-01-F